T4-B Symposium: Advancing Dose Response Assessment Sponsored by DRSGRoom: Baltimore B 3:30-5:00 PM
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| Chair(s): Michael Dourson, Jeff Gift
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T4-B.1 15:30 A Foundation for Including Quantitative Data in Health Risk Assessment. Lipscomb JC*; U.S. EPA
Abstract: Data first, defaults thereafter. Questions regarding the reliability of quantitative toxicokinetic (TK) and toxicodynamic (TD) data have been addressed by the International Programme on Chemical Safety. The Chemical Specific Adjustment Factors (CSAF) guidance document from the WHO/IPCS informs risk assessors of the considerations that should be given to quantitative data that may serve as the basis upon which to replace default values for inter and intraspecies extrapolation. Key considerations include determining the toxicologically-active chemical species, choosing the most appropriate measure of dose and documenting the relevance of the measured biological response to the health endpoint under consideration, and carefully considering the experimental data including relevance of the human population or samples, relevance of the route and dose, and considering whether the number of samples is statistically adequate. The IPCS has established a framework of default values for inter and intraspecies TK and TD uncertainty factors into which quantitative measures of TK and TD variability can be placed. This guidance fosters a reduction in the uncertainty in health risk assessment and strives to encourage the development of additional, quantitatively-valuable data.
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T4-B.2 15:50 Mixtures, thresholds and background response: How do they all relate? Hertzberg R*; Biomathematics Consulting hertzberg_rc@bellsouth.net
Abstract: Background incidence of toxic effects should influence the approach to dose-response assessment of environmental chemical risks. Options exist for recasting this problem, such as a mixture exposure (perhaps with an unknown chemical causing the background response), a threshold estimation, or some combination of those concepts. When the focus is on noncancer toxicity, the dose dependence of toxic severity must also be considered. These alternative approaches and some numerical examples will be presented and contrasted with current EPA approaches to noncancer risk assessment.
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T4-B.3 16:10 Current progress on the implementation of ideas from the NAS 2008 report. Dourson ML*; Toxicology Excellence for Risk Assessment dourson@tera.org
Abstract: The NAS (2008) report on science and decisions and advancing risk assessment has been met with praise, skepticism, critique, but above all, interest. Although many of the described concepts have been developing over several years, novel approaches to using several of these concepts were proposed, and harmonization amongst cancer and noncancer dose response assessment methods were encouraged. Interest in the NAS report has continued unabated through a series of telecons both within the SRA and the Society of Toxicology. State and federal agencies are also looking at ways to implement some of the more significant recommendations. Progress on several issues will be described from a state's perspective, but also from the viewpoint of federal, industrial and environmental colleagues.
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